A Study to Investigate the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel When Given Alone and in Combination With Baxdrostat in Healthy Females of Non-childbearing Potential

NCT ID: NCT06657105

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-02-03

Brief Summary

The main purpose of the study is to assess the effect of multiple doses of baxdrostat on the pharmacokinetics (PK) of a single dose of combined oral ethinyl estradiol (EE) and levonorgestrel (LNG). Safety and tolerability of baxdrostat will be assessed during the study.

Detailed Description

This is an open-label, 3-period fixed sequence study conducted at a single Clinical Unit.

The study will comprise of:

• A Screening period of maximum 28 days.
• Period 1: - From Day -1 to Day 5.
• Period 2: -From Day 6 to Day 16
• Period 3: - From Day 17 to Day 23.
• A Final Follow-up Visit, 7 (± 2) days after the last PK sample in Period 3.

Conditions

Healthy Participants

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Period 1: Ethinyl estradiol/Levonorgestrel (EE/LNG)

Participants will receive oral dose of EE/LNG in the fasted state on Day ,1 followed by PK sampling of EE/LNG for 120 hours (EE 72 hours and LNG 120 hours).

Group Type: EXPERIMENTAL

EE/LNG

Intervention Type: DRUG

EE/LNG tablet will be administered orally.

Period 2: Baxdrostat

Participants will self-administer the baxdrostat tablet once a day from Day 6 to Day 16.

Group Type: EXPERIMENTAL

Baxdrostat

Intervention Type: DRUG

Baxdrostat tablet will be administered orally.

Period 3: Baxdrostat + EE/LNG

Participants will receive baxdrostat once daily on Day 17 to Day 22 and will receive EE+LNG in the fasted state on Day 18, followed by oral dose of EE/LNG PK sampling for 120 hours (EE=72 hours and LNG=120 hours).

Group Type: EXPERIMENTAL

EE/LNG

Intervention Type: DRUG

EE/LNG tablet will be administered orally.

Baxdrostat

Intervention Type: DRUG

Baxdrostat tablet will be administered orally.

Interventions

EE/LNG

EE/LNG tablet will be administered orally.

Intervention Type: DRUG

Baxdrostat

Baxdrostat tablet will be administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Females must have a negative pregnancy test at the Screening Visit and Study Day -1 (admission to Clinical Unit) and must not be lactating and must be of non-childbearing potential, confirmed at Screening by fulfilling one of the following criteria:

1. Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range (Follicular Stimulating Hormone (FSH) > 40 mIU/mL).

2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.

• Have a Body Mass Index (BMI) between 18 and 30 kg/m2

Exclusion Criteria

• History of any clinically important disease or disorder which, in the opinion of the Investigator
• History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Sex hormone therapy within one month before study.
• History of drug-related hepatic toxicity.
• History or family history of potential risk of arterial and venous thromboembolic events (eg, factor V Leiden mutation).
• History of cardiovascular risk (eg, history of myocardial infarction).
• Any laboratory values with the following deviations at the Screening Visit and Study Day -1 (admission to Clinical Unit).
• Any positive result on screening for serum HBsAg, HBcAb, HCV or HIV.
• History of any treatment with QT prolongation drugs.
• Current smokers or know history of alcohol or drug abuse.
• History or ongoing severe allergy/hypersensitivity.
• An increased risk for developing SAEs or a contraindication associated with administration of EE, or LNG such as history of thrombosis or thromboembolism, presence of estrogen dependent tumors, hypertension, migraines, and liver disease.
• Participants treated with strong CYP3A4 inhibitors or inducers within 3 months or longer (5 half-lives) prior to first administration of IMP in this study.
• Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
• Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longest) of the first administration of IMP in this study.
• Participants who are vegans or have medical dietary restrictions and vulnerable participants.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Brooklyn, Maryland, United States

Countries

United States

Other Identifiers

D6970C00006

Identifier Type: -

Identifier Source: org_study_id